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Randomized Controlled Trial
. 2007 Dec 1;91(2-3):205-12.
doi: 10.1016/j.drugalcdep.2007.05.021. Epub 2007 Jul 12.

A double-blind, placebo-controlled trial of reserpine for the treatment of cocaine dependence

Theresa Winhusen  1 , Eugene Somoza, Ofra Sarid-Segal, R Jeffrey Goldsmith, Judy M Harrer, Florence S Coleman, Roberta Kahn, Sabuhi Osman, Juris Mezinskis, Shou-Hua Li, Daniel Lewis, Maryam Afshar, Domenic A Ciraulo, Paul Horn, Margaret A Montgomery, Ahmed Elkashef
Affiliations
Randomized Controlled Trial

A double-blind, placebo-controlled trial of reserpine for the treatment of cocaine dependence

Theresa Winhusen et al. Drug Alcohol Depend. .

Abstract

Background: Cocaine's increase of dopamine is strongly associated with its reinforcing properties and, thus, agents that reduce dopamine have received much attention as candidate cocaine-dependence treatments. The potential efficacy of reserpine, a dopamine depletor, for treating cocaine dependence is suggested by both pre-clinical research and a small clinical trial.

Method: One hundred and nineteen participants who met DSM-IV criteria for cocaine dependence were enrolled into this 12-week, double-blind, placebo-controlled outpatient trial. Participants received either reserpine (0.5 mg/day) or matching placebo. All participants received 1h of manualized individual cognitive behavioral therapy on a weekly basis. Outcome measures included cocaine use as determined by self-report confirmed with urine benzoylecgonine results, cocaine craving, addiction severity index scores, and clinical global impression scores. Safety measures included adverse events, EKGs, vital signs, laboratory tests, and the Hamilton Depression Inventory.

Results: Seventy-nine participants (i.e., 66%) completed the 12-week trial. The safety results suggest that reserpine was safe and well tolerated by the participants. The efficacy measures indicated no significant differences between reserpine and placebo.

Conclusion: These results do not support the efficacy of reserpine as a cocaine-dependence treatment.

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Figures

Figure 1
Figure 1
Mean proportion of cocaine non-use days as a function of medication group and study week
Figure 2
Figure 2
Mean Urine BE level as a function of medication group and study week.
See this image and copyright information in PMC

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